CATO SMS Thought Leadership

CATO SMS Thought Leadership

  • New FDA Gudiances for June 2020 and Upcoming…
    by Cato Research on July 5, 2020 at 9:53 pm

    By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry – Final Guidance 30 Jun 2020 Review and Update of Device Establishment […]

  • New FDA Gudiances for May 2020 and Upcoming…
    by Cato Research on June 8, 2020 at 8:06 pm

    By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) – Final Guidance 28 May 2020 Required Warnings for Cigarette Packages and […]

  • What’s New Health Canada?
    by Cato Research on May 7, 2020 at 9:44 pm

    By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate   What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: […]

  • New FDA Gudiances for April 2020 and Upcoming…
    by Cato Research on May 1, 2020 at 9:21 pm

    By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final […]

  • Consideration for ongoing clinical trials:…
    by Cato Research on April 29, 2020 at 1:00 pm

    By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In […]